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Trial registered on ANZCTR


Registration number
ACTRN12614000970640
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
10/09/2014
Date last updated
18/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
vaxSMS: A randomised controlled trial of text messaging and calendar reminders for improving immunisation timeliness in areas of low immunisation coverage
Scientific title
vaxSMS: A randomised controlled trial of text messaging and calendar reminders for improving immunisation timeliness in areas of low immunisation coverage
Secondary ID [1] 285165 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunisation timeliness 292756 0
Condition category
Condition code
Public Health 293046 293046 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are evaluating the effectiveness of a tablet computer application (app) in encouraging on time immunisation. The app is designed to be used by immunisation service providers (ISP) staff. It provides parents or carers with automatic SMS reminders 2 weeks and 2 days before upcoming immunisation dates and personalised calendars with each child's photograph and routine childhood immunisation dates up until the age of 4 years. Parents of children less than 16 months will be recruited at participating ISPs and randomly allocated to one of 4 groups: 1) SMS reminder messages, 2) calendar, 3) SMS reminder messages and calendar, and 4) no intervention. Timeliness of vaccine receipt, as recorded in the Australian Childhood Immunisation Register (ACIR), will be compared in the four groups. We will be recruiting from a range of immunisation service providers nationwide, including Aboriginal Medical Services and culturally and linguistically diverse group practices. This will have important implications for strategies to improve vaccination uptake, particularly in communities where vaccine coverage is low.
Intervention code [1] 290017 0
Prevention
Intervention code [2] 290208 0
Behaviour
Comparator / control treatment
No reminders
Control group
Active

Outcomes
Primary outcome [1] 292918 0
On-time immunisation (within 1 month of immunisation scheduled date), assessed using data linkage to Australian Childhood Immunisation Register (ACIR)
Timepoint [1] 292918 0
See National Immunisation Program schedule for vaccination due dates; participants will be followed up from recruitment up to 19 months of age or until study completion. (Whilst the app provides reminders up until the age of 4, we will only be analysing data up until the age of 19 months due to study time constraints.)
Secondary outcome [1] 309932 0
Assess app useability and acceptability will be assessed using structured qualitative interviews with parents/carers and immunisation service providers.
Timepoint [1] 309932 0
Parents/carers will be eligible for interview 1 month post intervention; interviews of parents/carers and immunisation service providers will be staggered across the study period.

Eligibility
Key inclusion criteria
Parents or carers of children, less than 16 months of age, who own a mobile phone and agree to participate.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study participants will be recruited by staff at immunisation service providers. Allocation (concealed) is performed by the app following entering of patient details.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Comparison differences in proportion of children vaccinated on-time by intervention groups using the chi-squared test. Preliminary sample size calculations have been performed assuming that the baseline proportion of on-time immunisations is between 60-80% and the expected improvement is between 10-15%.From these calculations, the expected sample size we would need is around 300-400 per intervention/control group, therefore around 1200-1600 vaccine doses. We estimate that this amount of vaccine doses will be achieved with around 1000 children since many children will be receiving multiple doses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 289777 0
Commercial sector/Industry
Name [1] 289777 0
bioCSL
Address [1] 289777 0
63 Poplar Road, Parkville Victoria 3052
Country [1] 289777 0
Australia
Primary sponsor type
Individual
Name
Dr Rob Menzies
Address
NCIRS
Cnr Hawkesbury Rd and Hainsworth St
The Children's Hospital
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 288466 0
Individual
Name [1] 288466 0
A/Prof Helen Marshall
Address [1] 288466 0
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and University of Adelaide
72 King William Rd
North Adelaide, SA 5006
Country [1] 288466 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291507 0
Sydney Childrens Hospital Network
Ethics committee address [1] 291507 0
The Children's Hospital Westmead
Cnr Hawkesbury Road and Hainsworth Street,
Westmead, NSW Australia 2145
Ethics committee country [1] 291507 0
Australia
Date submitted for ethics approval [1] 291507 0
Approval date [1] 291507 0
05/08/2014
Ethics approval number [1] 291507 0
HREC.14.SCHN.196

Summary
Brief summary
We are evaluating the effectiveness of a tablet computer application (app), which provides SMS and calendar reminders, in encouraging on time immunisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50686 0
Dr Leon Heron
Address 50686 0
Kids Research Institute
The Children's Hospital Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia 2145
Country 50686 0
Australia
Phone 50686 0
+61 2 9845 1232
Fax 50686 0
Email 50686 0
leon.heron@health.nsw.gov.au
Contact person for public queries
Name 50687 0
Ms Jennifer Lampard
Address 50687 0
Kids Research Institute
The Children's Hospital Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia 2145
Country 50687 0
Australia
Phone 50687 0
+61438233066
Fax 50687 0
Email 50687 0
Jennifer.lampard@health.nsw.gov.au
Contact person for scientific queries
Name 50688 0
Dr Jocelyn Chan
Address 50688 0
Kids Research Institute
The Children's Hospital Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia 2145
Country 50688 0
Australia
Phone 50688 0
+61 2 9845 1232
Fax 50688 0
Email 50688 0
jocelyn.chan@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary